BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1032418 · Received April 15, 2008

    Report

    Report Number
    6000002-2008-06526
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH DEVICES WERE RETURNED AND EVALUATED. UNIT #1 - NO BLOOD VISIBLE ON THE THERMISTOR CONNECTOR. NO VISIBLE INCONSISTENCIES OBSERVED ON THE EEPROM DATA. THERMISTOR AND THERMAL FILAMENT WERE CONTINUOUS. NO ERROR MESSAGE ON VIGILANCE I AND II MONITORS. ALL THROUGH LUMENS PATENT. BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR MORE THAN 5 MINUTES. NO VISIBLE DAMAGE TO CATHETER BODY. BOTH THERMISTOR AND THERMAL FILAMENT CONNECTORS WERE OPENED WITH NO VISIBLE INCONSISTENCIES. NO VISIBLE DAMAGE TO CATHETER BODY. UNIT #2 - HEAVY BLOOD RESIDUE WAS VISIBLE AT THE THERMISTOR CONNECTOR. TWO SLITS WERE FOUND, 0.09" IN LENGTH, AT THE 12.5 CM AREA (DISTAL OF THERMAL FILAMENT) AND 0.03" IN LENGTH, AT THE 24.3 CM AREA (PROXIMAL OF THERMAL FILAMENT) WHICH ENTERED INTO THE THERMISTOR LUMEN. A CAPA IS IN PROCESS FOR SLIT IN CATHETER BODY RELATED TO THERMISTOR LEAKAGE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD WAS LEAKING FROM THE THERMISTOR PORT. TWO CATHETERS, SAME MODEL NUMBER WERE REPORTED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 746F8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other